Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI

Revision Skincare

Status: Completed

Conditions: Overall Appearance; Radiance; Skin Smoothness

Treatments: Other: Post Procedure Cream; Other: sunscreen; Other: Gentle Cleanser; Other: Facial Moisturizer; Other: Biocellulose Mask

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06633731

RS-2023-01

Details and patient eligibility

About

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.

Full description

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Enrollment: 11 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals with Fitzpatrick Skin Type V and VI
• Individuals with mild to moderate global facial radiance, skin smoothness, and overall appearance (Score 2 - 6 on a 10-point modified Griffiths scale).
• Individuals willing to undergo a washout period of 3 days.

Exclusion criteria

• Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study.
• Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Topical Treatment

Experimental group

Description:

Subjects received a topical facial treatment applied by a license esthetician in a series of 3 sessions at 1 month intervals. The treatment included a topical treatment, biocellulose mask, and serum. Additionally, subjects followed a 12 weeks skincare regimen including a gentle cleanser, bland moisturizer, and bland sunscreen.

Treatment:

Other: Biocellulose Mask

Other: Facial Moisturizer

Other: Gentle Cleanser

Other: sunscreen

Other: Post Procedure Cream